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Pfizer Xeljanz Label Expansion Application Accepted by FDA

Pfizer Inc.’s PFE supplemental new drug application (sNDA) for Xeljanz has been accepted for review by the FDA. Xeljanz (5 mg twice daily), a JAK inhibitor, is presently approved in the U.S. as a second-line treatment for moderate-to-severely active rheumatoid arthritis (RA) in patients who have had an inadequate response to or cannot tolerate methotrexate. The drug was approved in Europe and China in March this year for RA.

With the latest application, the company is looking to get the drug’s label expanded to include treatment of adult patients suffering from moderate-to-severe active ulcerative colitis (UC). A response from the FDA is expected in March next year.

Pfizer’s shares are up 2.5% so far this year, comparing unfavorably with the Zacks classified Large-Cap Pharma industry’s gain of 11.3%.

The acceptance of the sNDA was based on data from three pivotal studies from the OCTAVE global clinical development program constituting of OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain. It also included data from an open label extension study of Xeljanz, evaluating its long-term effects in patients who had completed treatment or had failure in OCTAVE Sustain, or did not respond to treatment in OCTAVE 1 or 2.

The data from the studies demonstrated that Xeljanz was more effective than placebo in inducing and maintaining remission in patients. Data showed that 18.5% patients were in remission compared to 8.2% for placebo in OCTAVE 1 whereas 16.6% patients were in remission versus 3.6% for placebo in OCTAVE 2 at week 8. OCTAVE Sustain, evaluating two different administrations, achieved remission in 34.3% (5mg) and 40.6% (10mg) of patients compared to 11.1% for placebo at week 52.

OCTAVE Induction 1 and 2 studies evaluated the induction of remission for a twice daily 10mg oral administration of the drug in patients with UC. OCTAVE Sustain evaluated Xeljanz (5mg and 10 mg) as maintenance therapy in patients including those who achieved at least clinical response in OCTAVE Induction 1 or 2.

We are encouraged by Pfizer’s label expansion efforts. Xeljanz U.S. sales were up 27% year over year to $250 million in the first quarter of 2017. Label expansion of the drug should boost sales further.

Meanwhile, another sNDA for Xeljanz is under review in the U.S. for psoriatic arthritis, which was filed in May this year. A response from the agency is expected in Dec 2017.

AstraZeneca’s earnings estimates have increased from $1.84 to $1.85 for 2017 and from $1.83 to $1.89 for 2018 over the last 30 days. The company came up with a positive earnings surprise in each of the last four quarters, with an average beat of 142.6%. The share price of the company is up 18.5% so far this year.

Merck’s earnings estimates have moved up from $3.84 to $3.85 for 2017 and from $4.16 to $4.18 for 2018 over the last 60 days. The company came up with a positive earnings surprise in each of the last four quarters, with an average beat of 4.36%. The share price of the company is up 6.8% so far this year.

Sanofi’s earnings estimates have moved up from $3.08 to $3.18 for 2017 and from $3.26 to $3.30 for 2018 over the last 60 days. The company came up with positive earnings surprise in two of the last four quarters, with an average beat of 5.10%. The share price of the company is up 20.3% so far this year.

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